Tobramycin Injection, Solution
NDC Package 63323-306-30

11-digit billing NDC: 63323030630 · Billing unit: ML · 300 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Tobramycin (tobramycin sulfate) injection is to reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin Injection, USP and other antibacterial drugs, Tobramycin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-306 and is authorized under FDA application ANDA065122.

Identification & Billing

NDC Package Code
63323-306-30
Package Description
10 VIAL, MULTI-DOSE in 1 TRAY / 30 mL in 1 VIAL, MULTI-DOSE (63323-306-05)
Product Code
63323-306
11-Digit Billing Format
63323030630
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
300 ML

Clinical Specifications

Proprietary Name
Tobramycin
Non-Proprietary Name
Tobramycin Sulfate
Substance Name
Tobramycin Sulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TOBRAMYCIN SULFATE 40 mg/mL
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin Injection, USP and other antibacterial drugs, Tobramycin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.   Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli, and Klebsiella spp Lower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E. coli, and S. aureus (penicillinase- and non-penicillinase-producing strains) Serious central-nervous-system infections (meningitis) caused by susceptible organismsIntra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter spp Skin, bone, and skin structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, Serratia spp and S. aureusComplicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus spp (indole-positive and indole-negative), E. coli, Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus, Providencia spp, and Citrobacter spp Aminoglycosides, including tobramycin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.  Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin.  If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted.  In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin may be initiated before the results of susceptibility studies are obtained.  The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the  WARNINGS box.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065122
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2005
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3260
Source: ASP
Tobramycin sulfate injection
HCPCS Dosage 80 MG
Units / Pkg 150

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63323-306). Click a package code to view its specific billing and regulatory data.

63323-306-02
25 VIAL, MULTI-DOSE in 1 TRAY / 2 mL in 1 VIAL, MULTI-DOSE (63323-306-01)
63323-306-26
25 VIAL, MULTI-DOSE in 1 TRAY / 2 mL in 1 VIAL, MULTI-DOSE
63323-306-55
25 VIAL in 1 TRAY / 2 mL in 1 VIAL
63323-306-56
10 VIAL in 1 TRAY / 30 mL in 1 VIAL

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-306-30 identifies a specific commercial package of 10 vial, multi-dose in 1 tray / 30 ml in 1 vial, multi-dose (63323-306-05) of Tobramycin, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intramuscular; intravenous use and contains tobramycin sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on November 23, 2005. The current certification is valid through December 31, 2027.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323030630. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 300 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63323-306-30
11-Digit CMS (5-4-2)
63323-0306-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.